www.fdanews.com/articles/195973-fda-hands-breakthrough-device-status-to-cardiovalves-valve-replacement-system
FDA Hands Breakthrough Device Status to Cardiovalve’s Valve Replacement System
February 21, 2020
Cardiovalve received breakthrough device designation from the FDA for its transcatheter tricuspid valve replacement system.
The FDA has approved an early feasibility study of the system for treatment of tricuspid regurgitation and mitral regurgitation.
The device imitates surgical replacement and can be used by 90 percent of the patient population, the company said.